Expanded Testing, Linkage, and Treatment for HIV Prevention Among MSM in China

针对男男性行为者（MSM）的全球艾滋病毒控制工作的成功将取决于干预措施的有效性和可持续性，以及干预方案的实施效率。一个可以检验的假设是，一揽子预防干预措施可能会产生重大影响，即使单一的方法不那么令人印象深刻。我们进一步假设，由于改善了社区对受欢迎的一揽子服务的支持，组合干预措施将比单独干预措施更具可持续性。一套针对艾滋病毒的干预措施被称为“检测和护理联系”。薄层层析背后的理论是，艾滋病毒感染者的比例增加，他们知道自己的状态，连接到艾滋病毒联合抗逆转录病毒治疗（cART）为基础的护理，谁坚持cART将减少病毒在社区中传播的数量。薄层层析与减少风险干预相结合，并在个人层面制定，可促进个人参与和承诺护理，减少对他人的传染性，同时增强和恢复个人健康。薄层色谱法旨在减少“社区病毒载量”，通过降低艾滋病毒感染者的传染性来降低未感染者的风险。 我们在这项为期一年的临床试验计划（R34）拨款中的目标是准备一项社区水平的随机临床试验（RCT），以测试我们的多组分TLC干预方案在降低中国MSM中HIV发病率方面的有效性。通过与中国CDC网络和当地MSM社区组织合作，我们将制定启动RCT所需的所有文件，完成实施试验所需的所有当地、联邦和国际人类受试者和监管机构的批准，并确定临床试验地点和建立临床试验的社区咨询委员会。在研究结束时，我们将准备好一份RCT方案，用于测试两个研究假设：（1）在接受24个月TLC干预的社区中，MSM将实现相对于标准预防社区中MSM的HIV发病率降低;（2）与标准预防方法相比，TLC干预将改善治疗成功和风险降低的次要和中间指标。 公共卫生相关性：我们的研究提案代表了对艾滋病预防的生物医学和行为方法的整合的创新适应，其承诺得到流行病学数据的支持，但从未在中国的临床试验设计中进行过测试。该基金将为一项临床试验做准备，在该试验中，中国不知道自己状况的男男性行为者（MSM）将接受检测，这些感染HIV的MSM将受益于可用的cART延长寿命。以患者为中心的预防将能够针对未被识别的艾滋病毒感染者或感染艾滋病毒的高危人群，从而有效地防止进一步传播。

DESCRIPTION (provided by applicant): The success of global HIV control efforts for men who have sex with men (MSM) will depend on how effective and sustainable the interventions are, but also how efficiently the intervention programs are implemented. A testable hypothesis is that a package of prevention interventions may have a substantial impact even if single approaches are less impressive. We further hypothesize that combination interventions will be even more sustainable than isolated interventions, due to improved community support of a popular package of services. One package of HIV-specific interventions has been termed "test-and-linkage-to-care" (TLC). The theory behind TLC is that the increase in the proportion of HIV-infected persons who know their status, are bridged to HIV combination antiretroviral therapy (cART)-based care, and who adhere to cART will reduce the amount of virus circulating in a community. TLC integrated with risk reduction intervention and formulated at the individual-level can facilitate one's engagement and commitment in care, reducing infectiousness to others at the same time that personal health is enhanced and restored. TLC seeks to reduce "community viral load," reducing the risk to uninfected persons by reducing the infectiousness of HIV-infected individuals. Our goal in this one-year clinical trial planning (R34) grant is to prepare for a community-level randomized clinical trial (RCT) to test the efficacy of our multicomponent TLC intervention package to reduce HIV incidence among MSM in China. By collaborating with Chinese CDC networks and local MSM community based organizations, we will develop all documents required for initiation of an RCT, complete all local, federal, and international human subjects and regulatory approvals necessary for implementation of the trial, and identify clinical trial sites and establish community advisory boards for a clinical trial. At the end of the study, we will have a RCT protocol ready for testing two research hypotheses: (1) MSM in communities receiving 24 months of TLC intervention will achieve a reduction in HIV incidence relative to MSM in standard prevention communities; and (2) TLC intervention will improve secondary and intermediary indicators of treatment success and risk reduction, compared to the standard prevention approaches. PUBLIC HEALTH RELEVANCE: Our study proposal represents an innovative adaptation of an integration of biomedical and behavioral methods of HIV prevention whose promise is supported by epidemiological data, but has never been tested in a clinical trial design in China. This grant will prepare a clinical trial in which men who have sex with men (MSM) in China who are unaware of their status will be tested and those HIV-infected MSM will benefit from prolonged life by available cART. The patient-centered prevention will be able to target the unrecognized individuals with HIV infections or at high risk of contracting HIV such that the further transmission can be prevented effectively.